Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or 4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple compression data will be sampled using the NeoSuck RT software. The infant will remain connected to the usual NICU monitors at all times for observation of respiration, heartbeat and oxygen saturation.
After the NTrainer data collection is completed, the baby will be fed by his or her nurse or parents as directed in the care plan. If the baby is able to feed by mouth, one of the investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2 minutes of the feeding, and 2) an EFS assessment after the feeding is completed.
Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice weekly (2 sessions per day, 2 days per week) until hospital discharge.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27610
- WakeMed
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Born at 30 to 36 weeks gestation and have no exclusion criteria.
Exclusion Criteria:
- Significant birth defects.
- Breathing difficulties severe enough to require being on a ventilator or nasal CPAP for more than 2 hours after birth.
- Any oxygen requirement at Day 4 of life.
- Any neurologic problems, including seizures or frequent apnea spells.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Infants born at 30 to 36 weeks gestation
Infants will be considered eligible if they are born at 30 to 36 weeks gestation and have no exclusion criteria.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To describe NNS pressure waveforms and NNS-STI values in normal premature infants with gestational ages 30 to 36 weeks during the first week of life.
Periodo de tiempo: First Weeks of Life
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First Weeks of Life
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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To describe the progression of NNS waveform pattern and NNS-STI values in normal premature infants as they mature to term postmenstrual age.
Periodo de tiempo: Mature to full term postmenstrual age
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Mature to full term postmenstrual age
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Young, MD, WakeMed Health and Hospitals
Publicaciones y enlaces útiles
Publicaciones Generales
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WakeMed Study 748
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